The Orthopedic Technology Evidence Index

What is cleared—and what has actually been studied.

This index pairs public FDA records for spine-related AI devices with human studies, registered trials, recalls, and the limitations tied to the same function. For clinicians, researchers, trainees, and health-technology teams.

17curated platform families in this beta

4technology categories

Quarterlyplanned verification

Aug 24, 2026research cutoff

Explore the index

Start with the regulatory record.

17 of 17 platform families shown

Modular CT, synthetic-CT, or CTA processing software with clinician-reviewable machine-learning segmentation, spinopelvic measurements, pedicle-screw trajectory planning, 3D-model output, and a Correction module for planning and simulating aspects of pediatric and adult spine surgery.

Evidence snapshot

The latest family record, K260322, adds the Acorn 3D Correction module. Sponsor-submitted bench testing found simulated corrections met surgeon-defined angular inputs within 3°. The machine-learning segmentation function is carried forward from earlier family records; no exact peer-reviewed clinical evaluation was identified.

CTsegmentation3D planning

Latest included FDA record: K260322
510(k) review panel: Radiology
Product code: QIH / LLZ
Selected predicate / references: Acorn 3D · K252103; selected references K251532 / K141669 / K213975
Evidence-function match: Direct
Evidence independence: FDA-only
Safety search: No FDA recall linked to this submission found in the documented search
Last checked: Aug 24, 2026

FDA record ↗Clearance summary ↗

Authorization / AI ambiguity

Tracked separately pending clarification.

Public records do not clearly identify which authorized function is AI-enabled. Watchlist and FDA AI-list review cutoff: Aug 24, 2026.

Verification watchlist

Paradigm System

Proprio · K252950

The FDA summary describes CT segmentation, 3D modeling, topographic registration, navigation, and pedicle-cannulation support without identifying AI/ML. The device was not located on the current FDA AI-enabled list; manufacturer AI claims alone do not meet the inclusion rule.

Review FDA source ↗

Verification watchlist

xvision Spine System

Augmedics · K261854

The latest family record, K261854, was cleared July 31, 2026 with K251639 as its predicate. K251639 appears on the FDA AI-enabled list, but neither public summary clearly identifies which authorized function is AI-enabled. It remains on the watchlist pending an explicit primary-source description.

Review FDA source ↗

Verification watchlist

CoLumbo C-Spine

Smart Soft Healthcare · K254015

The summary describes automated cervical-spine segmentation but characterizes the relevant method as rule-based and does not explicitly identify an AI/ML function. It is tracked here rather than included in the staged index.

Review FDA source ↗

A deliberately narrow method

How entries are included and staged.

Identify

Find spine-relevant entries in FDA authorization records and group iterative submissions into platform families.

Verify

Confirm the cleared function, regulatory pathway, product code, and intended clinical use from primary documents.

Connect

Link key human studies, registered trials, and FDA recall records to the same platform family and identify version or function mismatches.

Stage

Report the highest evidence stage reached by the platform family without ranking products or implying that clearance equals superiority.

0Regulatory record onlyClearance plus bench or non-human testing; no human clinical validation located.1Human performance validationHuman data appear in FDA materials; no peer-reviewed study of the exact function located.2Clinical validityPeer-reviewed human evidence evaluates the exact or a materially matching function.3Clinical utilityEvidence evaluates effects on clinician performance, workflow, or decision-making.4Comparative patient outcomesProspective comparative evidence evaluates meaningful patient outcomes.

The stage reports the highest evidence type located for the platform family. It is not a product ranking or an overall quality score. Read the complete methods, matching rules, and search protocol →

Interpret with care

Transparent about what the data cannot say.

The FDA describes its AI-enabled device list as noncomprehensive. The list reviewed for this beta displayed decision dates through March 30, 2026, so absence of a later submission is not treated as evidence that a device lacks AI.

“No FDA recall linked to this submission found” does not mean no adverse events or family-level safety signals. Exact-submission and device-family searches are documented separately; MAUDE reports are signals, not incidence estimates or proof of causation.

Unverified commercial claims do not determine inclusion or stage. Sponsor-submitted performance data in FDA records may support Stage 0 or 1 and are labeled FDA-only. Published funding and author relationships inform the independence label.

This is a curated beta, not a formal systematic review. Information may be incomplete or become outdated; verify material decisions against the linked primary sources and review the change log.